Gemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 31, 2001

Primary Completion Date

December 31, 2004

Study Completion Date

May 31, 2005

Conditions
Leukemia
Interventions
DRUG

ara-C

3 g/sq m IV infusion over 3 hours Days 1-5

BIOLOGICAL

gemtuzumab ozogamicin

9 mg/sq m IV infusion over 2 hrs D 1 (Cohort I); D 7 (Cohorts II, IA, \& IV); \& D 14 (Cohort IV) 4.5 mg/sq m IV infusion over 2 hrs D 8 (Cohort I) \& D 14 (Cohort II)

Trial Locations (78)

10021

Memorial Sloan-Kettering Cancer Center, New York

New York Weill Cornell Cancer Center at Cornell University, New York

10029

Mount Sinai Medical Center, NY, New York

11030

CCOP - North Shore University Hospital, Manhasset

North Shore University Hospital, Manhasset

11373

Elmhurst Hospital Center, Elmhurst

11432

Queens Cancer Center of Queens Hospital, Jamaica

13210

University Hospital at State University of New York - Upstate Medical University, Syracuse

Veterans Affairs Medical Center - Syracuse, Syracuse

13217

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse

14215

Veterans Affairs Medical Center - Buffalo, Buffalo

19713

CCOP - Christiana Care Health Services, Newark

20007

Lombardi Cancer Center at Georgetown University Medical Center, Washington D.C.

20422

Veterans Affairs Medical Center - Washington, DC, Washington D.C.

21201

Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore

22902

Martha Jefferson Hospital, Charlottesville

23502

Virginia Oncology Associates - Norfolk, Norfolk

24014

Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke

25701

St. Mary's Medical Center, Huntington

27705

Veterans Affairs Medical Center - Durham, Durham

27710

Duke Comprehensive Cancer Center, Durham

28025

NorthEast Oncology Associates, Concord

28374

FirstHealth Moore Regional Hospital, Pinehurst

28805

Veterans Affairs Medical Center - Asheville, Asheville

32804

Florida Hospital Cancer Institute, Orlando

33021

Memorial Regional Hospital Comprehensive Cancer Center, Hollywood

33140

CCOP - Mount Sinai Medical Center, Miami Beach

33316

Broward General Medical Center, Fort Lauderdale

33401

Palm Beach Cancer Institute, West Palm Beach

36207

Northeast Alabama Regional Medical Center, Anniston

38103

University of Tennessee Cancer Institute, Memphis

38104

Veterans Affairs Medical Center - Memphis, Memphis

40207

Baptist Hospital East - Louisville, Louisville

49085

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph

52722

Hematology Oncology Associates of the Quad Cities, Bettendorf

55417

Veterans Affairs Medical Center - Minneapolis, Minneapolis

55455

University of Minnesota Cancer Center, Minneapolis

60305

West Suburban Center for Cancer Care, River Forest

60612

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago

60640

Louis A. Weiss Memorial Hospital, Chicago

61108

Saint Anthony Medical Center, Rockford

61602

CCOP - Illinois Oncology Research Association, Peoria

63110

Barnes-Jewish Hospital, St Louis

64131

CCOP - Kansas City, Kansas City

65201

Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia

65203

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia

73104

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center, Oklahoma City

75216

Veterans Affairs Medical Center - Dallas, Dallas

89106

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas

Veterans Affairs Medical Center - Las Vegas, Las Vegas

92161

Veterans Affairs Medical Center - San Diego, San Diego

94115

UCSF Comprehensive Cancer Center, San Francisco

94121

Veterans Affairs Medical Center - San Francisco, San Francisco

35233-1996

Veterans Affairs Medical Center - Birmingham, Birmingham

92093-0658

Rebecca and John Moores UCSD Cancer Center, La Jolla

20307-5000

Walter Reed Army Medical Center, Washington D.C.

60637-1470

University of Chicago Cancer Research Center, Chicago

46885-5099

Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne

52242-1009

Holden Comprehensive Cancer Center at University of Iowa, Iowa City

02115

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston

01655

University of Massachusetts Memorial Medical Center - University Campus, Worcester

68198-7680

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha

03106

New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett

03756-0002

Norris Cotton Cancer Center at Dartmouth Medical School, Lebanon

08103

Cooper University Hospital, Camden

27599-7295

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

28302-2000

Cape Fear Valley Health System, Fayetteville

28503-1678

Lenoir Memorial Hospital Cancer Center, Kinston

28402-9025

New Hanover Regional Medical Center, Wilmington

27104-4241

CCOP - Southeast Cancer Control Consortium, Winston-Salem

27157-1082

Comprehensive Cancer Center at Wake Forest University, Winston-Salem

43210-1240

Arthur G. James Cancer Hospital - Ohio State University, Columbus

02906

Lifespan: The Miriam Hospital, Providence

05201

Green Mountain Oncology Group, Bennington

05401-3498

Vermont Cancer Center at University of Vermont, Burlington

05009

Veterans Affairs Medical Center - White River Junction, White River Junction

23298-0037

MBCCOP - Massey Cancer Center, Richmond

00936-5067

University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Alliance for Clinical Trials in Oncology

OTHER

NCT00006265 - Gemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter